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Human recombinant endostatin (Endostar) combined with concurrent radiochemotherapy in patients with Inoperable stage III non-small cell lung cancer : a prospective, randomized controlled clinical study

Human recombinant endostatin (Endostar) combined with concurrent radiochemotherapy in patients with Inoperable stage III non-small cell lung cancer : a prospective, randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013479
Enrollment
Unknown
Registered
2017-11-21
Start date
2017-12-01
Completion date
Unknown
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inoperable stage III non-small cell lung cancer

Interventions

1:Endo combined with radiotherapy and chemotherapy on the 1st, 3rd, 5th and 7th week: Endostar: 7.5 mg / m2 / d × 7 days, continuous intravenous infusion, IMRT 6 to 7 weeks after the second week Stron

Sponsors

Affiliated hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years male and female; 2. The pathology / cytology was confirmed as non-small cell lung cancer, and the UICC 8th edition of TNM was stage III NSCLC inoperable; 3. Karnofsky score =70 points or ECOG 0-1 points; 4. Pulmonary function: FEV1> 50%, mild to moderate lung function impaired; 5. Evaluation criteria of solid tumor efficacy (RECIST1.1) measurable lesions; 6. blood: white blood cells = 4.0 × 10^9/L, neutrophils =2.0×10^9/L, platelets =100×10^9/L, hemoglobin =100g/L; 7. Blood biochemistry: Serum creatinine = 1.25 times upper limit of normal (ULN), serum creatinine clearance =60 mL/min, serum bilirubin = 1.5×ULN, AST and ALT <2.5×ULN, alkaline phosphatase = 5×ULN; 8. The first treatment for this treatment (no history of chest radiotherapy; no history of concurrent chemoradiation); 9. voluntarily joined the trial, signed informed consent, good compliance, with follow-up.

Exclusion criteria

Exclusion criteria: (1) lung carcinoid tumor or small cell lung cancer; (2) history of other malignant diseases, contraindications to radiotherapy and chemotherapy (important organ insufficiency, severe infection, unstable angina, heart failure, uncontrolled arrhythmia, valvular heart disease, malignant chest cavity within 6 months after myocardial infarction And / or pericardial effusion; (3) thrombosis or bleeding events (including hemoptysis, gastrointestinal bleeding, hematemesis, CNS bleeding, epistaxis, vaginal bleeding, cerebral infarction and transient ischemic attack) at 6 months; (4) active gastroduodenal ulcer, abdominal fistula and non-gastrointestinal fistula, gastrointestinal perforation or abdominal abscess occurred in June; (5) Previous NSCLC chemotherapy or chest irradiation, or any monoclonal antibody or small molecule inhibitor of VEGF / VEGFR treatment; (6) Patients who require permanent oral anticoagulants (such as warfarin, rivaroxaban, dabigatran, coumarin acetate, etc.); (7) stable antihypertensive treatment, poor blood pressure control or resting blood pressure> 150 / 100mmHg; (8) The presence of human immunodeficiency virus (HIV) infection, syphilis or active tuberculosis infection; (9) lesions can not be clearly identified or measured on CT; (10) Past allergy to biological agents; (11) pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Progressive survival;

Secondary

MeasureTime frame
Total survival;Objective response rate;Local progression-free survival;The incidence of toxic reactions;

Contacts

Public ContactYu-Ju Bai

Affiliated hospital of Zunyi Medical University

byi6618@163.com+86 13984535566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026